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Search / Trial NCT06823557

Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity.

Launched by UNIVERSIDADE DO PORTO · Feb 6, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Psychobiotic Treatment Study Of Neuro Psycho Biological Mechanisms Microbiota Gut Brain Axis (Mgba) Obesity Binge Eating Disorder

ClinConnect Summary

This clinical trial is studying a condition called Binge Eating Disorder (BED), where individuals frequently eat large amounts of food and feel a loss of control during these episodes. The trial aims to understand how a connection between the gut and the brain, known as the gut-brain axis, might influence binge eating and obesity. Researchers are particularly interested in a potential treatment called psychobiotics, which are special supplements that can help balance the bacteria in the gut and may improve symptoms of BED. By comparing participants taking these supplements to those receiving a placebo (a look-alike pill with no active ingredients), the study hopes to find out if psychobiotics can help reduce binge eating and support better eating habits.

To participate in this study, you need to be an adult living in Portugal with a history of BED, and there are specific criteria regarding weight and health conditions. Participants will take either the psychobiotic supplement or a placebo daily for 12 weeks and will undergo various assessments, including tests on gut bacteria, hormones, and psychological factors related to eating. After completing the trial, follow-up visits will occur three months later to see how symptoms have changed. This research is important as it may lead to new ways to help people struggling with BED and improve their overall well-being.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Portuguese adults (25 with normal weight; 25 with obesity only (30 ≤ BMI \< 40) and BED; 54 with BED)
  • Residents in Portugal for the past 10 years
  • Exclusion Criteria:
  • Significant weight loss (\>5% of body weight) in the past 2 years
  • Antibiotic use in the past 6 months
  • History of surgery or medical/psychiatric diseases
  • Pregnant or breastfeeding
  • History of drug use or dependence
  • Use of medications that impact weight
  • Have metal implants or pacemakers

About Universidade Do Porto

The Universidade do Porto, one of Portugal's leading academic institutions, is dedicated to advancing medical research and innovation through its clinical trial sponsorship. With a robust framework for interdisciplinary collaboration, the university fosters an environment that encourages the exploration of cutting-edge therapies and healthcare solutions. Leveraging its extensive network of researchers, clinical practitioners, and state-of-the-art facilities, the Universidade do Porto is committed to conducting high-quality, ethical clinical trials aimed at improving patient outcomes and contributing to the global body of medical knowledge.

Locations

Porto, Paranhos, Portugal

Patients applied

0 patients applied

Trial Officials

Eva M. Conceição

Principal Investigator

Center for Psychology at University of Porto (CPUP)

Clarisse N. Salomé

Principal Investigator

Center for Engineering Biological (CEB) at University of Minho

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported